Naloxone hydrochloride dihydrate

Drug ingredient

CAS 51481-60-8

This chemical is an active pharmaceutical ingredient used in FDA-regulated drugs.

Molecular structure of 51481-60-8
2 H₂O · 1 HCl
US productionNot reported
Import value, 2024$50M
Top sourceIndia 37%

This chemical is not on EPA’s Toxic Substances Control Act inventory, the list behind EPA’s production survey.

Why supply is unknown

Production is reported production, not a complete census of factories. Import value and source-country shares describe a shared customs category, not a separate chemical measurement.

Where It Comes From

Customs basis: HS 293919 · basket

These shares come from HS customs code 293919, which covers 12 tracked chemicals in total. They estimate the category's origin mix, not this chemical specifically.

Source Countries
IN 37%IndiaIT 16%ItalyGB 15%United KingdomDE 10%GermanyDK 10%Denmark
26 FDA-registered drug labelers
Accord Healthcare, Inc
Actavis Pharma, Inc.
Alvogen Inc.
American Health Packaging
Amneal Pharmaceuticals LLC
Asclemed USA, Inc.
AvPAK
Bryant Ranch Prepack
Camber Pharmaceuticals, Inc.
Clinical Solutions Wholesale, LLC
Hikma Pharmaceuticals USA Inc.
Macfarlan Smith Limited
Major Pharmaceuticals
Medisca Inc.
Mylan Pharmaceuticals Inc.
Noramco, LLC
Pharmaron Manufacturing Services (UK) Ltd
Professional Compounding Centers of America
Redpharm Drug
REMEDYREPACK INC.
Rhodes Pharmaceuticals L.P.
Siegfried PharmaChemikalien Minden Gmbh
SpecGx LLC
Spectrum Laboratory Products, Inc.
SUN PHARMACEUTICAL INDUSTRIES, INC.
Unit Dose Solutions, Inc.

Why It Matters

Sectors
Health
Downstream Uses

Appears in 4 drug and cosmetic product listings (FDA).

  • •Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
  • •Buprenorphine and Naloxone
  • •Buprenorphine and Naloxone Sublingual Film
  • •Buprenorphine HCl and Naloxone HCl
FDA Shortage Status
No FDA shortage records

Chemical Identity

CAS51481-60-8
PubChem CID20112022
DTXSIDDTXSID90199452
FormulaC19H26ClNO6
Mol. Weight399.9 g/mol
SMILESC=CCN1CCC23C4C(=O)CCC2(C1CC5=C3C(=C(C=C5)O)O4)O.O.O.Cl

Data Sources

Brief citations

Naloxone hydrochloride dihydrate (CAS 51481-60-8) https://chemicalindependence.com/chemical/51481-60-8/ PubChem: 20112022. Retrieved 2026-04-07. https://pubchem.ncbi.nlm.nih.gov/compound/20112022 FDA National Drug Code directory: CAS 51481-60-8. Retrieved 2026-04-25. https://open.fda.gov/data/ndc/ FDA National Drug Code directory: bulk match. Retrieved 2026-04-07. https://open.fda.gov/data/ndc/ US Census international trade: HS 293919 for CAS 51481-60-8. Reporting year: 2024. https://usatrade.census.gov/